Vismodegib

Embryo-Fetal Death and Severe Birth Defects

• Vismodegib (Erivedge) capsule can result in embryo-fetal death or severe birth defects.
• Vismodegib is embryotoxic and teratogenic in animals. Teratogenic effects included severe midline defects, missing digits, and other irreversible malformations.
• Verify pregnancy status prior to the initiation of vismodegib (Erivedge).
• Advise male and female patients of these risks. Advise female patients of the need for contraception and advise male patients of the potential of vismodegib (Erivedge) exposure through semen. [See Warnings and Precautions, Use in Specific Populations]

MONITORING RECOMMENDATIONS RELATED TO BLACK BOX DATA

• Verify pregnancy status prior to initiation of the drug
• Counsel patients regarding teratogenicity risk

Patient Counseling Information

• ERIVEDGE

Medication Guides

Patient Medication Guide

Package Inserts

Vismodegib